a study to compare the effect of a double dose of two long-acting insulin therapies in participants with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the primary purpose of this study is to compare the effect of a double dose of a study drug known as insulin peglispro to a double dose of insulin glargine in participants who have type 2 diabetes. participants will be treated with study insulin daily, in two 4-week study periods. each participant will receive insulin peglispro during one treatment period and insulin glargine during the other treatment period.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus (t2dm), based on the world health organization (who) classification, for ≥1 year. * use any type of basal insulin (except degludec), including once-or twice-daily human insulin neutral protamine hagedom (nph), insulin detemir, or insulin glargine. * have hemoglobin a1c (hba1c) levels ≤9.0% according to local laboratory testing at screening. * have body mass index (bmi) ≤40.0 kilograms/square meter (kg/m\^2). * have been treated with stable doses of insulin for at least 30 days before screening with: * basal insulin with daily doses ±30% of mean during the last 4 weeks. * doses of a basal insulin must be between 0.3 unit/kg/day and 1 unit/kg/day. * if on metformin, thiazolidinediones (tzds), sodium glucose co-transporter 2 (sglt-2) inhibitors, or dipeptidyl peptidase (dpp4) inhibitors, must be on stable doses for the last 30 days. exclusion criteria: * are using prandial, self-mixed, or premixed insulin. participants using prandial insulin may be switched to everyday (qd) glargine if investigator judges that the participant will still meet fasting glucose requirements for randomization. * are using insulin pump therapy. * have excessive insulin resistance: defined as \>1.0 unit/kg/day as baseline treatment. * if being treated with sulfonylureas (sus) before screening, then must have sus washed out between screening and randomization. * use any of these concomitant medications: morphine, codeine, antidiuretics, glucagon-like peptide-1 (glp-1) receptor agonists (for example, exenatide, exenatide once weekly, lixisenatide or liraglutide), or pramlintide, used concurrently or within 90 days before screening. * have hypoglycemia unawareness, defined as confirmed by laboratory test results or by historical episodes of hypoglycemia \<54 mg/dl (3.0 mmol/l) without symptoms. * have fasting hypertriglyceridemia \>400 mg/dl (\>4.5 mmol/l) at screening, as determined by the local laboratory. * have had any episode of severe hypoglycemia (defined by requiring assistance due to neurologically disabling hypoglycemia) within 6 months before entry into the study. * have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months. * have had a previous clinically significant episode of ketoacidosis as determined by the investigator (ketone bodies at fasting and without acidosis is acceptable) in the past 6 months. * have history of renal transplantation, are currently receiving renal dialysis, or have estimated glomerular filtration rate (egfr) \<60 milliliters/minute. * have obvious clinical signs or symptoms of liver disease (excluding nonalcoholic fatty liver disease), acute or chronic hepatitis, nonalcoholic steatohepatitis, or elevated liver enzyme measurements. * have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator.